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PKC412 in Patients With Acute Myeloid Leukemia and Patients With Myelodysplastic Syndrome With Either Wild Type or Mutated FLT3

This study has been completed.
Sponsor:
Collaborators:
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
University of California, Los Angeles
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00045942
First received: September 16, 2002
Last updated: November 18, 2009
Last verified: November 2009
History of Changes
  Purpose

Patients who agree to participate in this trial will be screened for the FLT 3 mutation by bone marrow exam. They will have a physical exam, blood test, EKG, chest x-ray, bone marrow aspirate and a pregnancy test. Patients will be required to have weekly blood test and bone marrow aspirate monthly.


Condition Intervention Phase
Acute Myeloid Leukemia
Myelodysplastic Syndromes
 Drug: PKC412, an inhibitor of FLT3
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Phase I/II Trial of PKC412 in Patients With Acute Myeloid Leukemia and Patients With Myelodysplastic Syndrome With Either Wild Type or Mutated FLT3

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • To determine the safety, tolerability and pharmacokinetics in AML and high-risk MDS patients when given PKC412 as monotherapy. [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assess safety [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]
  • Determine pharmacodynamic activity [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]
  • Assess changes in markers of efficacy and toxicity [ Time Frame: baseline, at each cycle during therapy and at study completion ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2002
Primary Completion Date: September 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PKC412 Drug: PKC412, an inhibitor of FLT3

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients:

    with AML who are not candidates for myelosuppressive chemotherapy or with AML who have relapsed disease or are refractory to standard therapy and not likely to require cytoreductive therapy within one month or with MDS subtypes RAEB, RAEB-T or CMML.

  2. Patients with a relevant FLT3-ITD mutation or D835Y point mutation
  3. Patients at least 18 years or older
  4. Patients with WHO performance status of 0 to 2 with a life expectancy of at least 3 months
  5. Patients must not be treated within 4 weeks after any prior therapy
  6. Written informed consent obtained according to local guidelines

Exclusion criteria:

Patients meeting any of the following criteria during screening will be excluded from entry into the study:

  1. Patients who had prior allogeneic, syngeneic, or autologous bone marrow transplant or stem cell transplant less than 2 months previously.
  2. Female patients who are pregnant or breast feeding, or adults of childbearing age not employing an effective method of birth control.
  3. Concurrent severe and/or uncontrolled medical or psychiatric condition which may interfere with the completion of the study.
  4. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of PKC412.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00045942

Locations
United States, California
UCLA Medical Center
Los Angeles, California, United States, 90095
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
United States, New York
New York Weill Cornell Medical Center
New York, New York, United States, 10021
Memorial Sloan Kettering Cancer Center
New York City, New York, United States, 10065
Sponsors and Collaborators
Novartis Pharmaceuticals
Dana-Farber Cancer Institute
Memorial Sloan-Kettering Cancer Center
Weill Medical College of Cornell University
University of California, Los Angeles
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00045942     History of Changes
Obsolete Identifiers: NCT00045578
Other Study ID Numbers: CPKC412 2104
Study First Received: September 16, 2002
Last Updated: November 18, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
AML
MDS
high risk myelodysplastic syndrome

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
 Hematologic Diseases
Precancerous Conditions
4'-N-benzoylstaurosporine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013